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A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma (HL)

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ClinicalTrials.gov Identifier: NCT01716806
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as a single-agent (Part A) and in combination with dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of HL in adults age 60 and above.

Condition or disease Intervention/treatment Phase
Hodgkin Disease Drug: brentuximab vedotin Drug: bendamustine Drug: dacarbazine Drug: nivolumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above
Actual Study Start Date : October 2012
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brentuximab Vedotin Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Experimental: Brentuximab Vedotin + Dacarbazine Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: dacarbazine
375 mg/m2 every 3 weeks by IV infusion

Experimental: Brentuximab Vedotin + Bendamustine Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: bendamustine
70 mg/m2 by IV infusion on Days 1 and 2 of 3-week cycle

Experimental: Brentuximab Vedotin + Nivolumab Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35

Drug: nivolumab
3 mg/kg every 3 weeks by IV infusion




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only) ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only) ]
  3. Complete remission rate (CR) [ Time Frame: Through 1 month following last dose ]
  4. Duration of response [ Time Frame: Participants will be followed for an average of 2 years ]
  5. Progression-free survival [ Time Frame: Participants will be followed for an average of 2 years ]
  6. B symptom resolution rate [ Time Frame: Through 1 month following last dose ]
  7. Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes ]
  8. Incidence of brentuximab vedotin antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose ]
  9. Blood concentrations of nivolumab and metabolites [ Time Frame: Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes ]
  10. Incidence of nivolumab antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma
  • Ineligible for or have declined initial conventional combination chemotherapy
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • ECOG performance status less than or equal to 3

Exclusion Criteria:

  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
  • Concurrent use of other investigational agents
  • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716806


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

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Sponsors and Collaborators
Seattle Genetics, Inc.
Bristol-Myers Squibb
Investigators
Study Director: Faith Galderisi, DO Seattle Genetics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01716806     History of Changes
Other Study ID Numbers: SGN35-015
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 31, 2018

Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate
Antibodies, Monoclonal
Hematologic Diseases
Hodgkin Disease
Antigens, CD30
Lymphoma
monomethylauristatin E
Drug Therapy

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Nivolumab
Bendamustine Hydrochloride
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action